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ACTIVE NOT RECRUITING
NCT03299426
PHASE3

Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).

Official title: A Phase III Randomized, Double-Blind, Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

Key Details

Gender

All

Age Range

9 Months - 12 Years

Study Type

INTERVENTIONAL

Enrollment

30000

Start Date

2018-02-21

Completion Date

2025-10-30

Last Updated

2025-05-30

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Vi-Typhoid Conjugate Vaccine (Vi-TCV)

Single 0.5-ml intramuscular injection

BIOLOGICAL

Meningococcal A Conjugate Vaccine (MCV-A)

Single intramuscular injection. Children 9-11 months will receive a 5µg/0.5ml dose. Children 12 months and older will receive a 10µg/0.5 ml dose.

Locations (1)

Malawi Liverpool Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital College of Medicine

Blantyre, Malawi